Healthcare Industry News: Gabapentin GR
News Release - July 5, 2007
Depomed Reacquires the Rights to ProQuin(R) XRMENLO PARK, Calif.--(HSMN NewsFeed)--Depomed, Inc. (NASDAQ: DEPO ) announced today it has ended the license agreement and the related supply and co-promotion agreements with Esprit Pharma for ProQuin® XR, the extended release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections.
Pursuant to the termination agreement, Esprit has paid Depomed $17,500,000. Esprit will also return the ownership of the Proquin NDA to Depomed along with all promotional materials. In addition, the parties have agreed to a detailed transition plan with specific activities and timelines related to the transition of the product from Esprit to Depomed. Depomed will leverage the commercial distribution network it has established for Glumetza to book sales and distribute Proquin in the US.
"We are happy to have ProQuin back," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "We believe ProQuin will be a success, and we are continuing our discussions with potential new partners. We worked closely with Esprit to unwind the ProQuin agreements in a manner that assures our ability to continue commercializing ProQuin and appreciate their efforts in reaching this amicable agreement."
About ProQuin® XR
ProQuin XR is a once-daily extended-release formulation of ciprofloxacin hydrochloride and is indicated to treat uncomplicated urinary tract infections (UTIs). UTIs are bacterial infections frequently caused by E. coli and are typically treated with antibiotics. Patients should not take Proquin XR if they are allergic to, or have ever had a severe reaction to, ciprofloxacin or to any other "quinolone" antibiotics. ProQuin XR is generally well tolerated. The most common side effects with ProQuin XR include vaginal yeast infection and headache.
Depomed, Inc., is a specialty pharmaceutical company with two approved products on the market and multiple product candidates in its pipeline. The company utilizes its proven, proprietary AcuForm(TM) drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Glumetza(TM) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is being marketed in the United States by King Pharmaceuticals and in Canada by Biovail Corporation. ProQuin® XR (ciprofloxacin hydrochloride) extended release tablets are approved in the United States for the once-daily treatment of uncomplicated urinary tract infections. Product candidate Gabapentin GR(TM) is currently in Phase 3 and Phase 2 clinical development for the treatment of two pain indications, postherpetic neuralgia and diabetic peripheral neuropathy, respectively. A Phase 2 clinical trial of Gabapentin GR in menopausal hot flashes is also underway. Additional information about Depomed may be found on its web site, www.depomedinc.com.
"Safe Harbor" Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. The inclusion of forward-looking statements, including those related to the transition of ProQuin XR to Depomed and the commercialization of ProQuin XR, should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation, risks and uncertainties related to: our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; our ability to successfully commercialize our products; the success of our collaborative arrangements with development and commercialization partners; and other risks detailed in our filings with the Securities and Exchange Commission filings, including our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. We undertake no obligation to revise or update this release to reflect events or circumstances that occur after the date of this release.
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